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G Scott Gazelle

Publications and source records attributed to G Scott Gazelle.

At least 19 recordsLinked to original sources

Use of modeling to evaluate the cost-effectiveness of cancer screening programs.

Cost-effectiveness analysis (CEA) is an analytic tool that provides a framework for comparing the health benefits and resource expenditures associated with competing medical and public health interventions, thereby allowing decision makers to identify interventions that yield the greatest amount of health, given their resource constraints. Models are important components of most, if not all, CEAs, and they play a key role in evaluating the cost-effectiveness of cancer screening programs, in particular. In this article, we describe the basic types of models used to evaluate cancer screening programs and provide examples of the use of models in CEAs and to guide cancer screening policy. Finally, we offer some suggestions for important concepts to consider when interpreting model results.

Cost-Benefit Analysis↗

Cost-effectiveness of using N-terminal pro-brain natriuretic peptide to guide the diagnostic assessment and management of dyspneic patients in the emergency department.

The cost-effectiveness of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) in dyspneic patients in emergency departments (EDs) is unknown. The objective of this study was to assess the cost-effectiveness of NT-pro-BNP testing for the evaluation and initial management of patients with dyspnea in the ED setting. A decision model was developed to evaluate the cost-effectiveness of diagnostic assessment and patient management guided by NT-pro-BNP, compared with standard clinical assessment. The model includes the diagnostic accuracy of the 2 strategies for congestive heart failure and resulting events at 60-day follow-up. Clinical data were obtained from a prospective blinded study of 599 patients presenting to the ED with dyspnea. Costs were based on the Massachusetts General Hospital cost accounting database. The model predicted serious adverse events during follow-up (i.e., urgent care visits, repeat ED presentations, rehospitalizations) and direct medical costs for echocardiograms and hospitalizations. NT-pro-BNP-guided assessment was associated with a 1.6% relative reduction of serious adverse event risk and a 9.4% reduction in costs, translating into savings of $474 per patient, compared with standard clinical assessment. In a sensitivity analysis considering mortality, NT-pro-BNP testing was associated with a 1.0% relative reduction in post-discharge mortality. The optimal use of NT-pro-BNP guidance could reduce the use of echocardiography by up to 58%, prevent 13% of initial hospitalizations, and reduce hospital days by 12%. In conclusion, on the basis of this model, the use of NT-pro-BNP in the diagnostic assessment and subsequent management of patients with dyspnea in the ED setting could lead to improved patient care while providing substantial cost savings to the health care system.

Biomarkers↗

Quality of life in patients with various Barrett's esophagus associated health states.

BACKGROUND: The management of Barrett's esophagus (BE), particularly high grade dysplasia (HGD), is an area of much debate and controversy. Surgical esophagectomy, intensive endoscopic surveillance and mucosal ablative techniques, especially photodynamic therapy (PDT), have been proposed as possible management strategies. The purpose of this study was to determine the health related quality of life associated with Barrett's esophagus and many of the pivotal health states associated with Barrett's HGD management. METHODS: 20 patients with Barrett's esophagus were enrolled in a pilot survey study at a large urban hospital. The utility of Barrett's esophagus without dysplasia (current health state) as well as various health states associated with HGD management (hypothetical states as the subject did not have HGD) were measured using a validated health utility instrument (Paper Standard Gamble). These specific health states were chosen for the study because they are considered pivotal in Barrett's HGD decision making. Information regarding Barrett's HGD was presented to the subject in a standardized format that was designed to be easily comprehendible. RESULTS: The average utility scores (0-1 with 0 = death and 1 = perfect health) for the various Barrett's esophagus associated states were: BE without dysplasia-0.95; Post-esophagectomy for HGD with dysphagia-0.92; Post-PDT for HGD with recurrence uncertainty-0.93; Post-PDT for HGD with recurrence uncertainty and dysphagia-0.91; Intensive endoscopic surveillance for HGD-0.90. CONCLUSION: We present the scores for utilities associated with Barrett's esophagus as well as various states associated with the management of HGD. The results of our study may be useful in advising patients and providers regarding expected outcomes of the various HGD management strategies as well as providing utility scores for future cost-effectiveness analyses.

Aged↗

Risks and benefits of infliximab for the treatment of Crohn's disease.

BACKGROUND & AIMS: Infliximab is effective for the treatment of active Crohn's disease. However, rare but serious complications related to infliximab therapy including lymphoma, sepsis, and death have been reported. The purpose of this study was to analyze the risks and benefits of infliximab for the treatment of Crohn's disease with the goal of providing data to aid both physicians and patients in the process of making a decision about treatment. METHODS: A decision analytic model was constructed to determine the risks and benefits of infliximab when compared with standard therapy. The analysis simulated 2 cohorts of 100,000 patients each, with one arm receiving infliximab while the other remained on standard therapy. RESULTS: Model results showed that in 100,000 patients at 1 year, infliximab will lead to 12,216 more patients in remission, 4255 fewer surgeries, and 33 fewer deaths from flares of disease. This is at the cost of 201 more lymphomas and 249 more deaths related to complications from infliximab. Overall, the infliximab strategy resulted in more quality-adjusted life years (QALYs/patient) than the standard therapy strategy (.77 QALYs/patient vs .75 QALYs/patient). CONCLUSIONS: Despite an increased risk of lymphoma and death associated with use of infliximab, the substantial clinical improvement and fewer surgeries as a result of infliximab result in an increase in QALYs. In properly selected patients, the benefits of infliximab could outweigh its risks. These data should help guide decision making and the informed consent process when considering the use of infliximab for the treatment of Crohn's disease.

Adult↗

Coxibs versus combination NSAID and PPI therapy for chronic pain: an exploration of the risks, benefits, and costs.

OBJECTIVE: To systematically review studies qualitatively to compare the risks (gastrointestinal [GI] and cardiovascular) and benefits (pain control) of cyclooxygenase-2 inhibitors (coxibs) relative to an alternative therapy of a nonselective nonsteroidal antiinflammatory drug (NSAID) combined with a proton-pump inhibitor (PPI) and explore circumstances when coxibs may be appropriate. METHODS: Relevant studies were identified through a search of MEDLINE (Ovid Technologies, 1985-November 2005; English language, clinical trial), PubMed (1985-November 2005; English language, clinical trial, humans), and the Cochrane Collaboration using the terms selective COX-2 inhibitors and coxibs, as well as the various chemical names for specific coxib agents. Studies that compared a coxib with a nonselective NSAID and provided data concerning our outcomes of interest were included and categorized by the outcome variable, as well as by the specific coxib studied. RESULTS: The majority of the numerous studies that evaluated pain as an endpoint showed no difference between coxib and nonselective NSAID therapy. However, while limited, preliminary safety data regarding the effects of both classes on the upper and lower GI tract suggest coxib superiority. Although coxibs are associated with an increased risk of cardiovascular adverse events (CVEs) compared with placebo, this effect has not been conclusively shown compared with nonselective NSAIDs. Currently, coxib therapy is more expensive than combination therapy using a nonselective NSAID plus a PPI. CONCLUSIONS: Compared with combination therapy including a nonselective NSAID and PPI, coxibs provide equivalent pain control and may have a lower GI tract complication profile, but at an unknown increased risk of CVEs and a greater financial cost. Coxib therapy may be an appropriate treatment for chronic pain in select patients with higher risks of GI complications, lower risk of CVEs, and in whom greater cost is not a restraint.

Anti-Inflammatory Agents, Non-Steroidal↗

Biomedical Imaging Research Opportunities Workshop III: a white paper.

The third Biomedical Imaging Research Opportunities Workshop (BIROW III) was held on March 11-12, 2005, in Bethesda, MD. The workshop addressed four areas of imaging that present opportunities for research and development: Multimodality Image-Guided Therapy, Imaging Informatics, Imaging Cell Trafficking, and Technology Improvement and Commercialization. The first three areas were individually addressed in their own plenary sessions, followed by audience discussions that explored research opportunities and challenges. This paper synthesizes these discussions into a strategy for future research directions in biomedical imaging.

Biomedical Engineering↗

Implications and cost of pancreatic leak following distal pancreatic resection.

OBJECTIVES: Pancreatic stump leak (PL) after elective distal pancreatic resection significantly impacts cost and increases subsequent health care resource utilization. We sought to provide an economic framework for potential interventions aimed at reducing its occurrence. DESIGN: Retrospective case series and economic evaluation. SETTING: University-affiliated, tertiary care referral center. PATIENTS: Sixty-six patients undergoing elective distal pancreatectomy. MAIN OUTCOME MEASURES: Postoperative complications; hospital and professional costs. RESULTS: Overall postoperative morbidity occurred in 34 patients (52%) with no deaths. The total number of patients with complications directly related to PL was 22 (33%). The mean +/- SD number of total hospital days for the no-PL group was 5.2 +/- 1.7 days (range, 3-12 days) vs 16.6 +/- 14.6 days (range, 4-49 days) for the PL group (P = .001). The average patient with PL-related problems incurred a total cost that was 2.01 times greater than the average patient in the no-PL group. A decision analytic model developed to evaluate threshold costs showed that a hypothetical intervention designed to reduce the complication rate of distal pancreatectomy by one third would be financially justifiable up to a cost of $1418 per patient. CONCLUSIONS: Complications derived from PL following distal pancreatectomy double the cost and dramatically increase health care resource utilization. There is an urgent need to develop strategies that reduce the incidence of this common complication. Interventions aimed at decreasing the incidence of PL should take into account this cost differential. We provide an economic model to serve as a guide for developing these technologies.

Adult↗

A systematic meta-analysis of the efficacy and heterogeneity of disease management programs in congestive heart failure.

BACKGROUND: We sought to systematically combine the evidence on efficacy of disease management programs (DMPs) in the treatment of congestive heart failure (CHF), to identify and explain heterogeneity of results from prior studies of DMPs, and to assess potential publication bias from these studies. METHODS AND RESULTS: We conducted a systematic literature search on randomized clinical trials investigating the effect of DMPs on CHF outcomes and performed meta-analyses and meta-regressions comparing DMPs and standard care for mortality and rehospitalization. We included 36 studies from 13 different countries (with data from 8341 patients). Our meta-analysis yielded a pooled risk difference of 3% (95% confidence interval [CI] 1-6%, P < .01) for mortality and of 8% (95% CI 5-11%, P < .0001) for rehospitalization, both favoring DMP. Factors explaining heterogeneity between studies included severity of disease, proportion of beta-blocker at baseline, country, duration of follow-up, and mode of postdischarge contact. No statistically significant publication bias was detected. CONCLUSION: DMPs have the potential to reduce morbidity and mortality for patients with CHF. The benefit of the intervention depends on age, severity of disease, guideline-based treatment at baseline, and DMP modalities. Future studies should directly compare the effect of different aspects of disease management programs for different populations.

Age Factors↗

Cost of an informatics-based diabetes management program.

OBJECTIVES: The relatively high cost of information technology systems may be a barrier to hospitals thinking of adopting this technology. The experiences of early adopters may facilitate decision making for hospitals less able to risk their limited resources. This study identifies the costs to design, develop, implement, and operate an innovative informatics-based registry and disease management system (POPMAN) to manage type 2 diabetes in a primary care setting. METHODS: The various cost components of POPMAN were systematically identified and collected. RESULTS: POPMAN cost 450,000 dollars to develop and operate over 3.5 years (1999-2003). Approximately 250,000 dollars of these costs are one-time expenditures or sunk costs. Annual operating costs are expected to range from 90,000 dollars to 110,000 dollars translating to approximately 90 dollars per patient for a 1,200 patient registry. CONCLUSIONS: The cost of POPMAN is comparable to the costs of other quality-improving interventions for patients with diabetes. Modifications to POPMAN for adaptation to other chronic diseases or to interface with new electronic medical record systems will require additional investment but should not be as high as initial development costs. POPMAN provides a means of tracking progress against negotiated quality targets, allowing hospitals to negotiate pay for performance incentives with insurers that may exceed the annual operating cost of POPMAN. As a result, the quality of care of patients with diabetes through use of POPMAN could be improved at a minimal net cost to hospitals.

Costs and Cost Analysis↗

Long-term acceptance of renal allografts following prenatal inoculation with adult bone marrow.

BACKGROUND: The aim was to investigate if intravascular in utero injection of adult bone marrow into swine fetuses could lead to macrochimerism and tolerance to the donor. METHODS: Outbred Yorkshire sows and boars screening negative for MHC allele SLA of MGH miniature swine were bred. A laparotomy was performed on the sows at 50 days gestation to expose the uterus. Bone marrow harvested from SLA miniature swine was T-cell depleted and injected intravascularly into seventeen fetuses. Flow cytometry was performed to detect donor cells (chimerism) in the peripheral blood after birth. Mixed lymphocyte reactions (MLR) and cell-mediated lympholysis (CML) assays were used to assess the response to donor MHC. Previously frozen skin grafts from the bone marrow donor were placed on the offspring from the first litter. Donor-matched renal transplant from SLA donors were performed on chimeric swine, with and without a short 12-day course of cyclosporine, and one nonchimeric littermate. RESULTS: Nine inoculated offspring demonstrated donor cell chimerism in the peripheral blood and lymphohematopoietic tissues. All animals with detectable chimerism within the first three weeks were consistently nonreactive to donor MHC in vitro. Animals challenged with donor skin grafts displayed prolonged graft survival without producing antidonor antibodies. All chimeric animals accepted donor-matched kidney allografts, even one without cyclosporine. The kidney in the nonchimeric littermate rejected by day 21. CONCLUSIONS: Transplantation of allogeneic adult bone marrow into immunocompetent fetal recipients resulted in chimerism. In utero inoculation led to operational tolerance to the donor's major histocompatibility antigens and long-term acceptance to organ allografts.

Animals↗

Diagnostic imaging costs: are they driving up the costs of hospital care?

PURPOSE: To retrospectively determine how changes in utilization of computed tomography (CT), magnetic resonance (MR) imaging, and other imaging technologies between 1996 and 2002 influenced costs of inpatient hospital care at one large academic medical center. MATERIALS AND METHODS: Institutional review board did not require its approval or patient informed consent for studies with use of billing data. Patient anonymity was protected by removal of potentially identifying information. Data on hospital costs for 17 139 patients admitted to Massachusetts General Hospital, Boston, Mass, between 1996 and 2002 were downloaded from hospital cost-accounting system; sample was restricted to inpatients with diagnoses in diagnosis-related groups 014-015 (Stroke and TIA [transient ischemic attack]), 164-167 (Appendectomy), 082 (Lung Cancer), 182-183 (Upper Gastrointestinal Conditions), 148-149 (Colon Cancer), and 243 (Back Problems). For each patient, data on demographics, all products and services used, and costs associated with each product or service were obtained. By using institutional codes, we calculated costs of CT, MR imaging, and total imaging relative to total hospital costs. Statistical analyses were performed with Student t test and multiple linear regression analysis. RESULTS: Between 1996 and 2002, number of inpatient CT and MR images obtained at the hospital more than doubled. In 2002, hospital costs were 155% those of 1996 levels; inpatient imaging costs were 151% those of 1996 levels. Total costs increased an average of 7.8% per year; imaging costs increased 8.3% per year. Although highly variable over the study period, as a percentage of total imaging costs, CT and MR imaging costs appeared to remain stable relative to costs of other imaging modalities. CONCLUSION: Despite substantial increases in utilization of inpatient CT, MR imaging, and other imaging technologies, diagnostic imaging costs increased at approximately same rate as did total costs for inpatients with several diagnoses. CT and MR imaging do not appear to be driving the cost increases seen between 1996 and 2002.

Costs and Cost Analysis↗

Patient preferences for the management of high-grade dysplasia in Barrett's esophagus.

Surgical esophagectomy, intensive endoscopic surveillance, and mucosal ablative techniques, particularly photodynamic therapy (PDT), have been proposed as possible management strategies for Barrett's high-grade dysplasia (HGD). Each option has advantages and disadvantages, and no firm consensus exists for the preferred strategy at this time. The purpose of this pilot study was to gain insight into patient preferences in Barrett's HGD management. Twenty patients with Barrett's esophagus were enrolled in a questionnaire study. The three possible management options for Barrett's HGD including each option's potential benefits and harms were presented to the subject in a formalized presentation that was designed to be easily comprehendible by patients. The subjects rated each strategy using a health-related quality of life instrument and chose one of the management strategies assuming they were found to have HGD. The average feeling thermometer rating scale values for the management strategies were as follows: endoscopic surveillance, 79; esophagectomy, 46; and PDT, 60. When asked to choose a strategy, 14 (70%) chose endoscopic surveillance, 3 (15%) chose esophagectomy, and 3 (15%) chose PDT. These findings were statistically significant (P = 0.0024). The patients who chose endoscopic surveillance felt "comfortable" with endoscopy, while the most common concern about esophagectomy, and PDT was the risk of death and the unknown risk of recurrence, respectively. In summary, when patients with Barrett's esophagus were presented with three options to manage HGD, the majority chose endoscopic surveillance. Familiarity with endoscopic surveillance was the predominant reason for the choice.

Aged↗

The effect of prior colonic imaging on endoscopic productivity: potential impact of computed tomographic colonography.

BACKGROUND & AIMS: If computed tomographic colonography (CTC) is used for primary colorectal cancer (CRC) screening with a small polyp size threshold to define a CTC study as positive, a substantial portion of all colonoscopies performed annually will be to follow up positive CTC examinations. Moreover, the majority of positive CTC examinations would be false positives (FP). This case-control study was undertaken to test the hypothesis that colonoscopy examinations resulting from FP CTC studies would take longer to complete than negative screening colonoscopies. METHODS: Endoscopic records of a large, urban hospital were reviewed to identify all patients who had either a positive barium enema (BE) study or flexible sigmoidoscopy (FS) and a negative follow-up colonoscopy examination (these patients were used as surrogates for CTC FP cases). For each of the 28 FP patients or cases identified, 2 screening colonoscopies performed by the same endoscopist within the same time period were identified and used as matched controls. A two-way analysis of variance test was performed to assess for differences in time to complete colonoscopies between these 2 groups, controlling for the individual endoscopist. RESULTS: FP colonoscopies took an average of 24.0 minutes to complete, whereas negative screening colonoscopies took 14.9 minutes; FP colonoscopies required 61% more active time to complete. This highly statistically significant difference (P < .0001) persisted with subset analyses that only included BE or FS cases and when fellow or surgeon cases were excluded. CONCLUSIONS: FP colonoscopies take longer to perform than negative screening colonoscopies. If CTC is implemented as the primary modality for CRC screening, these FP examinations could comprise a substantial percentage of the colonoscopies performed, potentially leading to a significant decrease in endoscopic productivity.

Adult↗

A cost-effectiveness analysis of a hypothetical catheter-based strategy for the detection and treatment of vulnerable coronary plaques with drug-eluting stents.

AIM: Extensive efforts are underway to develop methods for the detection and treatment of vulnerable/high-risk coronary artery plaques. We utilized decision analysis to evaluate the hypothetical clinical benefits and cost-effectiveness of a catheter-based strategy. METHODS AND RESULTS: Currently, stenotic coronary plaques are treated without regard to vulnerability. In a new strategy, vulnerable coronary plaques are detected with a catheter-based test and treated with a drug-eluting stent, regardless of degree of stenosis. A Markov-decision model was developed to compare the new strategy with current practice. Monte Carlo simulations were performed from a societal perspective, costs were converted to year 2003 U.S. dollars, and future costs and outcomes were discounted at 3%. Sensitivity analyses were performed to evaluate the effect of assumptions on variables such as the prevalence of vulnerable plaques and treatment effect. In 60-year-old male patients with coronary stenoses the new strategy would be less expensive and more effective than current practice (37,045 dollars vs 38,257 dollars and 10.23 vs 9.86 quality-adjusted life years (QALYs), respectively). The benefits of the new strategy were robust in sensitivity analyses (e.g., if the prevalence of vulnerable plaques in this patient group was 50% or more and the sensitivity and specificity of the new test were at least 0.80). CONCLUSION: In selected patients with coronary artery stenosis, the detection of vulnerable plaques with a catheter-based test followed by their treatment with a drug-eluting stent could be a less expensive and more effective strategy than current practice. If applied to 1 million such patients in the United States undergoing catheterization, the new strategy would add 370,000 QALYs and save 1.2 billion dollars per year.

Blood Vessel Prosthesis Implantation↗

Cost-effectiveness of whole-body CT screening.

PURPOSE: To make preliminary estimates of the effectiveness (in life-years) and cost-effectiveness (in costs per life-year) of whole-body computed tomographic (CT) screening. MATERIALS AND METHODS: Costs and effectiveness (in life-years) of onetime whole-body CT screening relative to those of no screening were calculated by using a decision-analytic model. It was assumed that any benefits from screening were due to earlier detection of disease and improvement in survival relative to survival with routine care. Eight conditions were included in the model: ovarian, pancreatic, lung, liver, kidney, and colon cancer; abdominal aortic aneurysm; and coronary artery disease. Costs of the screening examination, follow-up tests, and patient care were estimated. The base-case analysis was performed for a hypothetical cohort of 500 000 self-referred asymptomatic 50-year-old men. For sensitivity analyses, the age and sex of the cohort were varied. Results were expressed in 2001 U.S. dollars per life-year gained. RESULTS: Compared with routine care, whole-body CT screening provided minimal gains in life expectancy (0.016 6 years or 6 days) at an average additional cost of 2513 dollars per patient, or an incremental cost-effectiveness ratio of 151 000 dollars per life-year gained. Most patients (90.8%) had at least one positive finding, but only 2.0% had disease; work-up in patients with a false-positive result of screening accounted for 32.3% of total costs (1720 dollars of 5332 dollars). Results were sensitive to the prevalence of disease, the effect of screening on stage of disease at diagnosis, the specificity of screening, and the costs of follow-up for false-positive findings. CONCLUSION: Even with assumptions favorable to whole-body CT, implementation of onetime screening would not be cost-effective compared with currently funded medical interventions; follow-up for false-positive findings would add a substantial financial burden to the health care system.

Cost-Benefit Analysis↗

Cost-effectiveness analysis in the assessment of diagnostic imaging technologies.

In many ways, diagnostic technologies differ from therapeutic medical technologies. Perhaps most important, diagnostic technologies do not generally directly affect long-term patient outcomes. Instead, the results of diagnostic tests can influence the care of patients; in that way, diagnostic tests may affect long-term outcomes. Because of this, the benefits associated with the use of a specific diagnostic technology will depend on the performance characteristics (eg, sensitivity and specificity) of the test, as well as other factors, such as prevalence of disease and effectiveness of available treatments for the disease in question. The fact that diagnostic tests affect short-term, or "surrogate," outcomes, rather than long-term patient outcomes makes evaluation of these tests more complicated than the evaluation of therapeutic technologies. This article will trace the history of technology assessment in medicine, address the role of cost-effectiveness and decision analysis in health technology assessment, and describe unique features and approaches to assessing diagnostic technologies. The article will then conclude with a consideration of the limits of medical technology assessment.

Cost-Benefit Analysis↗

Analysis of aspirin-associated risks in healthy individuals.

BACKGROUND: Aspirin therapy is widely accepted for patients with documented cardiovascular disease, but there is a growing trend among healthy individuals to use aspirin as primary prevention for both cardiovascular disease and cancer. OBJECTIVE: To determine the impact of the complications of aspirin therapy on quality-adjusted life-years (QALYs) in healthy individuals. METHODS: A computer-based decision-analytic model was constructed. In this model, healthy individuals taking aspirin were assumed to receive no advantages from the aspirin, but were at risk of developing its associated complications. Individuals took 325 mg of enteric-coated aspirin every day until death, discontinuing therapy only if an aspirin-induced complication occurred. The analysis was performed from a societal perspective, starting at age 50 years. Extensive sensitivity analyses were performed. RESULTS: In the absence of any beneficial effect, aspirin reduced QALYs by 0.03 per individual. Unadjusted life expectancy was decreased by 0.04 years (2 wk). Lifetime aspirin use cost an average of $460/healthy person. The total complication rate over a lifetime of aspirin therapy was 6.79%, with a mortality rate of 0.18%. Alternatively stated, there was one complication for every 15 individuals treated and one death for every 556 individuals treated. Extensive sensitivity analysis showed the range of results possible when varying age, gender, length of follow-up, and other key parameters. CONCLUSIONS: Assuming no benefits, aspirin therapy in healthy individuals leads to a small reduction in QALYs at an overall low cost per person. However, approximately 1 in 15 individuals will experience an aspirin-induced complication and 1 in 556 individuals will die.

Adult↗